Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery

Jonsson Comprehensive Cancer Center

Status: Completed

Conditions: Prostate Cancer

Treatments: Dietary Supplement: green tea; Dietary Supplement: decaffeinated black tea; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00685516

CDR0000596162 (Other Identifier)

10-001050

R01CA116242 (U.S. NIH Grant/Contract)

UCLA-061109702 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Green tea contains ingredients that may prevent or slow the growth of certain cancers. It is not yet known whether green tea is more effective than black tea or water in treating prostate cancer.

PURPOSE: This randomized phase II trial is studying green tea to see how well it works compared with black tea and water in treating patients with prostate cancer undergoing surgery.

Full description

OBJECTIVES:

• to determine the effect of GT and BT consumption on apoptosis (TUNEL, ratio Bax:Bcl-2), proliferation, oxidation, and inflammation in malignant radical prostatectomy tissue compared to water control using immunohistochemistry.
• to examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and serum prostate-specific antigen (PSA) levels.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
• Arm II: Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
• Arm III: Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.

Patients undergo radical prostatectomy.

Blood and urine samples, as well as tissue from diagnostic biopsy and radical prostatectomy specimens, are obtained for laboratory correlative studies. Samples are assessed by IHC, high-performance liquid chromatography, or mass spectrometry for changes in prostate tumor grade, stage, and margin status; concentrations of total and free tea polyphenols (i.e., EGCG, EC, EGC, ECG), theaflavins, and conjugated/colonic tea metabolites; biomarkers of prostate cancer development and progression (i.e., serum PSA, proliferation [i.e., Ki-67], apoptosis [i.e., TUNEL, Bax/Bcl-2 ratio], inflammation [i.e., NFkB]), and oxidative status (i.e., 8OhdG/dG ratio); and genotype and gene expression of metabolizing enzymes (i.e., COMT, UGT, and SULT). Serum samples are also assessed by ex vivo LNCaP cell culture assay for antiproliferative activity and by competitive chemiluminescent immunoassay for concentrations of PSA, IGF-1, IGFBP-3, testosterone, SHBG, and DHEA-sulfate.

Enrollment: 113 patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subject consents to participate in the trial.
• subject is 40-75 years of age and has a diagnosis of adenocarcinoma of the prostate.
• Scheduled to undergo radical prostatectomy.
• The subject agrees to stop consumption of tea or tea-containing products throughout the entire intervention period except for the tea provided during study intervention.
• The subject agrees to stop consumption of dietary or vitamin supplements (e.g., lycopene, Vitamin E, selenium, genistein) or herbal supplements (e.g., saw palmetto, PC-SPES)

Exclusion criteria

• history of hepatitis or liver dysfunction
• ongoing alcohol abuse
• significant medical or psychiatric conditions that would make the patient a poor protocol candidate
• prior sensitivity or allergic reaction to tea, tea products, or tea supplements
• allergy or sensitivity to multiple food items or nutritional supplements
• concurrent luteinizing hormone-releasing hormone agonists, androgen receptor blocking agents, or finasteride
• prior bilateral orchiectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 3 patient groups, including a placebo group

Arm I - Green Tea

Active Comparator group

Description:

Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.

Treatment:

Dietary Supplement: green tea

Arm II - Water

Placebo Comparator group

Description:

Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.

Treatment:

Dietary Supplement: placebo

Arm III - Decaffeinated black tea

Active Comparator group

Description:

Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.

Treatment:

Dietary Supplement: decaffeinated black tea